Author: Jodi Fletcher

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Back to School, Back to Health Tips for a Healthy School Year

Back to School, Back to Health Tips for a Healthy School Year

By Jodi Fletcher

Summer is almost over and that means kids will be going back to school. Healthy kids are happy kids. There are some ways to ensure kids go back to school healthy and happy.

Yearly physical

Other than the occasional cold or flu, children don’t visit the doctor’s office often. A yearly physical examination enables the doctor to assess a child’s overall health. Back to school time is a perfect time to schedule these important screenings. The doctor will address important developmental concerns. They will also check the child’s heart and lungs. They may suggest nutritional and physical activity plans, as well as offering advice for children entering adolescence.

Nutrition

Since kids spend six to eight hours at school, what they are eating is important. According to the American Academy of Pediatrics (AAP), children consume 35% to 40% of their daily calories during the school day. Starting the day with a nutritious breakfast that includes protein can help a child focus better on their school activities. Some schools do provide breakfast for students. Not every child likes everything the school’s cafeteria offers. Luckily most schools provide parents with daily menus, so if a child does not like what is offered on a given day, a packed lunch can be planned. Lunches should consist of heart-healthy foods such as fruits and vegetables and lean protein. Foods high in sodium should be avoided. Soft drinks should also be avoided due to the high level of sugar and calories, which increase the risk of obesity, type 2 diabetes, and heart disease. Water, juice, or low-fat dairy products offer a healthier alternative. Schools offer different payment options for lunches, including free lunches to those who qualify. Every child should get enough to eat during their time at school.

Physical activity

Kids do plenty of sitting during the school day. That is why it is important to incorporate some physical activities into their day. According to the Centers for Disease Control and Prevention (CDC), children should participate in a minimum of 60 minutes of physical activity every day. This physical activity decreases the risk of obesity, type 2 diabetes, and heart disease.  Physical activity improves mental health, reducing stress and anxiety. The CDC breaks this recommendation down into three categories.

  • Moderate to vigorous intensity aerobic activity should make up most of the 60 minutes every day, with vigorous intensity activities 3 days per week.
    • On a scale of 0-10, moderate intensity activities are 5-6 and cause the heart to beat faster than normal. Vigorous intensity activities are 7-8 and cause the heart to beat even faster.
  • Muscle strengthening, such as gymnastics or push-ups, at least 3 days per week.
  • Bone strengthening, such as running, at least 3 days per week.

During the school day, children can participate in physical education, recess, and other classroom activities. After school, they can join athletic groups, playgroups, or participate in their favorite physical activity.

Sleep

 For many kids, summer is a time for staying up late and sleeping in. The days are longer and there is so much to do. However, as back to school approaches, kids need to get back into a better sleep schedule. Children who do not get enough sleep have a more difficult time concentrating and learning. Younger children need 10-12 hours of sleep, and getting up on time for school means getting to bed earlier than during the summer. According to the National Sleep Foundation and the Harvard Health Publishing, adolescents who don’t get enough sleep have an increased risk for higher cholesterol levels, higher body mass index, higher blood pressure, and hypertension. Limiting evening activities will help a child shift to use that time to do homework and study. A shift towards a consistent bedtime and wake time should begin at least a week before the start of school. This shift should also include limiting screen time. The AAP recommends that all devices should be removed from a child’s room at night and stop screen time at least one hour before bedtime.

Starting the new school year happy and healthy improves children’s ability to focus and learn. For more information about how to help with a child’s first day back to school go here.

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A Look at the Functional Service Provider

A Look at the Functional Service Provider

By Jodi Fletcher

What are functional service providers—FSPs–and how can they help you have a successful clinical trial?    

With so much data to analyze and process, documents to keep track of and regulations to follow in a clinical trial, outsourcing some of the work offers a cost effective and efficient approach.   Contract Research Organizations (CROs) have long been used by trial sponsors to achieve completion and compliance in clinical trials.  According to the Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice, the definition of a Contract Research Organization (CRO) is: “A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial related duties and functions.” 

Large, global companies have customarily outsourced responsibilities to full service CROs that perform multiple duties related to the trial, while smaller companies have often used “specialty CROs” designed to offer specialized services, such as source document monitoring, data management, or device training, where needed. However, in recent years, there has been a shift in how companies have been utilizing these organizations.  The increasing demand for complex clinical trials and the high overhead of building comprehensive, in-house, specialized clinical operations departments is driving the need for more outsourcing of services such as data management and analysis. Specialty CROs have filled this role in the past, but recently a re-branding of these organizations has more accurately labeled them as FSPs.  This model is becoming a more popular choice in both large and small sponsor companies.

The name of FSP for organizations providing high-level expertise in one or two areas of clinical operations has been gaining popularity because it more accurately delineates a full-service CRO from an organization which specializes. An FSP provides more flexibility and efficiency than traditional full-service providers. These organizations offer individual, focused services where the sponsor has the option to “pick and choose” which provider fits the area of the trial best. FSPs offer the option of expertise in the area of service or methodology. Companies may offer FSP services for clinical operations, data management, statistics, or medical writing. A sponsor may choose to use one or more FSPs for the trial, but it may also have several companies under contract per function to provide the most agile and complete coverage for individual studies.

FSPs, which can be generically referred to as functional outsourcing options, have become popular through the growing desire for a relationship driven approach rather than a project focused one.  Long term, flexible partnerships can be developed with targeted specialists, where several smaller vendors can be better than a single large one. Partnership development is crucial for the trial’s success. Partnerships in large CROs may take too long to develop because of the infrastructure necessary for a large vendor to operate and this may hinder startup or closure of certain trials.

Benefits of using an FSP:

  • Focused expertise
  • Competitive benefit
  • Risk mitigation
  • More efficient
  • Lower cost
  • Invested development in focused areas
  • Higher degree of control

Trust in the experience of the vendor is critical for a relationship to develop. This and cost are areas of concern in the process of service provider selection in clinical trials. (For more information go here and here) There are many ways that an FSP addresses these concerns. Often in an FSP arrangement, the technology and systems needed are provided by the sponsor, reducing the cost to invest in additional systems. This enables the sponsor to use existing personnel to focus on the management of the vendors and to oversee clinical operations.  In an FSP relationship, the vendor manages its staff, although the sponsor provides study-specific training and access to policies and procedures. This arrangement creates teams that are essentially an extension of the sponsors’ team. The result is increased transparency in the relationships that is easier to oversee and assess. An FSP relationship provides “senior-level governance, structure, and attention” throughout the process with this model aiming for efficient delivery while maintaining high quality and consistent service.

What to look for in an FSP:

  • Cultural and company values and strategies
    • Customer service approach, level of communication, conflict resolution, oversight
  • Experience and best practices
    • Does the company have plans in place based on what has worked previously?
  • Consistency
    • Turnover rates, human resource management
  • Flexibility to adapt
    • Strategic and proactive planning
  • Scalability to demand
    • Ability to tailor team relative to study size and complexity

The ability of the FSP to “fit” with the sponsor’s needs is imperative to the selection and the relationship that will be developed. Flexibility, integrity, trust, and experience are key factors in the success of the relationship.

Sometimes, a “one-size-fits-all” approach can be the right choice for a research service organization. However, in this era of specialization, an FSP may offer the most expertise and flexibility for the best results in your clinical trial.

WHAT SHOULD MONEY BUY? THE ETHICS OF ORGANS FOR SALE.

By Jodi Fletcher

How is value calculated? Webster Dictionary defines value as “the monetary worth of something” or “a fair return or equivalent in goods, services, or money for something exchanged” Should everything have a monetary worth? When it comes to how much a living organ is worth, there are factors that need to be considered. Is the organ worth more to the recipient, or to the donor? This is an ethical question that is hard to answer, but is a question in debate. 

There are multiple ethical facets to organ donation:

  1. First, do no harm:
    1. The donor has no medical need for surgery.
    2. There is a risk/benefit balance that needs to be considered. The organ recipient reaps disproportionate benefits compared to the donor.
  2. Informed consent: (for more information on informed consent go here)
    1. The donor must be competent and capable of understanding the risks involved.
    2. Must do so without any form of coercion.
  3. Regarding the question of financial compensation, vulnerable populations must be considered where a donor may lack the capacity to make an autonomous, voluntary decision to agree to donate an organ.

There is a shortage of organs for patients in need of transplants. According to U.S. Department of Health & Human Services there is a continuing decline in available donors. There is a question on how to obtain more organ donations. Proponents for selling organs are suggesting suspending or revoking the prohibitions of the National Organ Transplant Act of 1984 (NOTA). National Organ Transplant Act prohibits the sale of organs based on the idea of valuable consideration. According to the NOTA “The term “valuable consideration” does not include the reasonable payments associated with the removal, transplantation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of human organ in connection with the donation of the organ”. Current arguments for and against the selling of organs consider and evaluate several ethical questions.

Current arguments in favor of financial compensation for organs:

  1. Because demand for organs outpaces supply, it is believed that donation rates would increase if financial incentives were permitted.
  2. Organ donors are the only participants that receive no tangible benefits.
  3. Polls indicate societal support of compensation.
  4. Legal compensation of semen, hair, and plasma suggests the right of a person to use body parts as they wish.

Current arguments against compensation for organs:

  1. Potential abuse of vulnerable populations, such as those in a lower socioeconomic bracket.
  2. Reduction of altruistic donors who feel that compensation weakens their donations.
  3. Reduced donor disclosure due to motives based on compensation rather than altruism.
  4. Financial neutrality is a more ethical alternative.

For living organ donations such as kidney and liver transplants, the costs can add up for the donor. Travel, housing, and lost wages are all expenses that a living donor can incur. According to Warren, et. al.,  donors can incur an average of $6,000 in additional expenses. The goal of financial neutrality or at least the removal of “disincentives” is considered a more ethical approach to obtaining more donors.  

Proponents of financial neutrality suggest the coverage of:

  • Direct medical expenses: all pre and post donation costs related to the procedure
  • Direct nonmedical expenses: travel, housing, food, etc.
  • Indirect expenses: recovery time, lost wages

The recipient’s insurance may cover these expenses; however if it does not, there are organizations available to help. The National Living Donor Assistance Center (NLDAC) works to lessen the financial burden on donors through federal government grant funding.

            Although some countries allow the selling of organs, the theory of supply and demand may not be the best or most ethical motive. There are many other factors to consider.

Let us know your thoughts about the ethics of organ donation in the comments section. We’d love to hear from you!

Thanks for tuning in to the Hart Clinical Consultants Ethics Series!

JUNE IS MEN’S HEALTH MONTH – WEAR BLUE!

By Jodi Fletcher

Summer is a great time to ramp up those New Year’s health goals. The good weather and longer days don’t leave any room for excuses not to get healthy. The month of June has not only Father’s Day in it, but is dedicated as Men’s Health Month. That means time for men of all ages to take a closer look at their health. According to Menshealthmonth.org, the purpose of this month is “to heighten the awareness of preventable health problems and encourage early detection and treatment of disease among men and boys.” Federal, state, and local governments have declared the month of June as Men’s Health Month: to see your state’s proclamation go here. Awareness programs, activities, social media attention, and Men’s Health Week are just a few of the methods designed to encourage men to seek out information about their health. Family involvement is also an important factor in ensuring the men in our lives get the help they need towards longer, healthier lives.        

            Men’s health facts:

  • On average, men live 5 years less than women
  • 1 in 2 will develop cancer
  • Men have a higher death rate than women for most leading causes
  • Approximately 30,000 men in the U.S die yearly from prostate cancer
  • Men see the doctor half as much as women for preventative care
  • More men are uninsured than women

Common men’s health issues are managing chronic diseases such as diabetes, obesity, hypertension, heart disease, and high cholesterol. Other issues that affect health and quality of life are low testosterone and depression. Low testosterone affects sexual health, mood, memory, and energy. Low testosterone increases the risk of other chronic conditions as well. Prostate health problems are common in men, especially over the age of 50, although younger men can experience problems too. 

Prostate health issues:

  • BHP: benign prostatic hyperplasia is an enlarged prostate
    • Not cancerous
    • Most common in men over 50
    • Half of men age 50-60 and 90% by age 80
    • Causes discomfort and frequent, difficult urination
  • Prostate cancer
    • Most common
    • 2nd leading cancer resulting in death
    • No known prevention
  • Prostatitis
    • Inflammation possibly caused by infection
    • Most common in men under age 50

The American Cancer Society recommends that men with average risk factors for prostate cancer get regular screening at age 50. Risk factors include age, race/ethnicity, geography, family history and genetic mutations. Early detection is crucial for treatment. There are two main screening tests used for early detection. One is a blood test that determines the prostate-specific antigen (PSA) levels. The other test is a digital rectal exam (DRE) that checks the prostate.

Steps to improve health and stay healthy:

  • Eat healthy, include fruits and vegetables, and limit salt, sugar, and alcohol.
  • Participate in at least 2.5 hours of physical activity every week.
  • Quit smoking, for more information go here.
  • Reduce stress, try meditation or yoga.
  • Get regular checkups and preventative tests and screenings.
  • Know the signs and get help:
    • Heart attack: chest pain, weakness, pain in the arm/shoulder or neck/back, shortness of breath
    • Depression: sadness, grumpiness, hopelessness, fatigue, thoughts of suicide

Friday June, 15th is “Wear Blue Day” as a reminder of the importance of men’s health, but any day can be designated for group awareness building activities. Wear something blue to show your support, plan events, or create a fundraiser.   

Although the month of June is dedicated to men’s health, its message is important for the whole year. Join us in learning more about men’s health this month by going here  for more information.

Thanks for tuning in to Hart’s Healthy Tips!